Research News

Clinical trials pay dividends for patients

UB clinical trials benefit the community

By PATRICK KLINCK

“What’s most rewarding is when you get out into the community, meet people and see firsthand how your research is actually helping them lead healthier lives.”

Xiaozhong Wen, assistant professor

Division of Behavioral Medicine

Devina Linder, a Buffalo resident and mother of four, was able
to quit smoking during the first three of her four pregnancies, but
there was something different the fourth time around. Four months
into the pregnancy, she was still smoking 10 to 15 cigarettes a
day.

“I knew the damage that it was doing, but at that time I
just felt hopeless,” she says. “I didn’t feel
like I would be able to change anything.”

By chance, she saw a poster in her obstetrician’s office
asking for volunteers for a maternal smoking-cessation program, a
clinical study under the direction of principal investigator
Xiaozhong Wen, assistant professor in the Division of Behavioral
Medicine in the Department of Pediatrics, Jacobs School of Medicine
and Biomedical Sciences.

“I wasn’t sure what to expect,” Linder says.
“I wasn’t sure being part of the study was going to
help. It just brought different emotions. When you’re
pregnant you have a whole bunch of different emotions.”

Linder wouldn’t have known this, but her successful
participation in Wen’s maternal smoking-cessation program is
just one way Western New Yorkers are benefitting from the growth of
clinical research on the Buffalo Niagara Medical Campus, all led by
UB’s health sciences schools.

“Similar to other researchers, we do care about
data,” Wen says, “but what’s most rewarding is
when you get out into the community, meet people and see firsthand
how your research is actually helping them lead healthier
lives.

“The big reward for me is we can make a difference in the
mother’s health and also the health of the next
generation.”

Getting with the program

When people participate in clinical trials, they typically enjoy
better health outcomes. This is particularly true among populations
who lack access to regular health care, probably due to the extra
care and attention they receive from the clinical trial staff.

Wen’s research program has two aims: to test an innovative
method of smoking cessation during pregnancy, and to study the
correlation between maternal smoking and childhood obesity.
Although children born to women who smoke during pregnancy often
have low birth weight, paradoxically, maternal smoking during
pregnancy is one of the best predictors of pediatric obesity later
in life.

In the months following birth, babies born to mothers who smoke
often undergo a period of rapid infant weight gain, surpassing
their peers and setting a pattern of weight gain that may persist
into childhood.

“If you look at the evidence, it’s very consistent
across countries, across decades,” Wen says.
“That’s why we are trying to use smoking cessation
during pregnancy to prevent childhood obesity.”

In addition to education and counseling, one of the important
components of Wen’s treatment program is monitoring feedback.
Patients are tested for two harmful chemicals during pregnancy:
carbon monoxide and cotinine, a byproduct of nicotine. While
checking for compliance, Wen is also able to show mothers the
benefits of quitting smoking in real time as they watch levels of
these two toxins in their bodies drop the longer they stay off
tobacco. That means their growing children are also receiving less
exposure.

“I think about that, and I think about the information
that I’ve read, and I realize … they are smoking a
cigarette right along with me,” Linder says. “Why force
them to smoke a cigarette when that’s something they
didn’t choose to do?”

Her daughter just celebrated her first birthday and, this time
around, Linder has not gone back to smoking. She learned techniques
to deal with cravings through Wen’s program, such as finding
a distraction or focusing on her breathing. These have helped her
cope with the stressors that previously drove her back to the
habit.

Stuck waiting for a bus on her way to a recent appointment,
Linder chose one of her adaptive techniques.

“I pulled out my phone and I started playing Scrabble,
with my daughter sitting in the stroller looking right up at me,
laughing, and I said, ‘You know what, the cigarette’s
not even worth it.’”

“We are so glad to see that our intervention really
works,” Wen said. “So far, we can get about 63 percent
of mothers to quit smoking completely during pregnancy.
That’s not just based on self-reporting; it’s based on
our two biochemical tests. Our data show that those babies are born
normal at birth and have normal growth.”

Besides being a shining example of the impact UB’s growing
clinical research programs are having for patients, Wen’s
maternal smoking-cessation program also is a prototype for
recruiting and serving Buffalo’s traditionally underserved
neighborhoods. Wen’s study showed how UB research helps
reduce health disparities in the region while enhancing the
relevance of the research findings.

Recruiting a more representative population

By far, most women who smoke while pregnant come from
socioeconomically disadvantaged backgrounds. Most people who
volunteer for clinical trials do not.

UB’s Clinical and Translational Science Institute (CTSI)
Translational Pilot Studies Program, which funded this initial
phase of Wen’s research program, provides seed money to
advance promising new therapies. Top priority is given to projects,
such as Wen’s, that address health care disparities in
underserved or underrepresented populations in Western New
York.

“Dr. Wen’s study is exactly the kind of study on
which the CTSI places a high priority,” says Timothy Murphy,
SUNY Distinguished Professor of Medicine and the CTSI’s
director. “This innovative study included members of our
community who are traditionally excluded from the benefits of
participating in clinical research.”

Underrepresented minorities account for less than 10 percent of
people enrolled in clinical trials nationally, according to Murphy,
yet the population of the city of Buffalo is 50 percent
minority.

Wen’s study population reflects the demographics of the
group most at risk for maternal smoking. Eighty-six percent of the
women were recruited from two of Buffalo’s chronically
underserved neighborhoods: 14 percent from the West Side and 58
percent from the East Side. About 70 percent of the women in
Wen’s group were African-American, Hispanic or Native
American. More than 60 percent were single and more than 70 percent
unemployed. About 80 percent had a high school or lower level of
education.

Teresa Quattrin, UB Distinguished Professor and chair of the
Department of Pediatrics, heads up the CTSI’s special
populations core. She was instrumental in helping to enlist this
diverse group of volunteers. “I am extremely proud of Dr.
Wen’s effort to include women with social disparities and
move his research to the community,” she says.

For now, Wen’s team is monitoring the growth of the babies
in his program up to 2 years of age. Using data gathered in this
pilot study, he is now in the process of applying for federal
funding to continue the program and expand it.

“Child obesity is epidemic in this country, and many other
countries, and it can cause a lot of health issues,” Wen
says. “We know that obese kids are much more likely to be
obese adults. And adult obesity is tied to a host of health
problems, from diabetes to cardiovascular disease to
cancer.”

Recruiting volunteers in underserved and underrepresented
neighborhoods continues to be a challenge for clinical researchers
seeking a more representative population for their studies. Linder
says she understands the reluctance some people might feel about
volunteering based on a number of high-profile studies in the past
— prior to strict FDA regulation — that misled or
exploited subjects.

“You don’t know what to expect,” Linder says.
“You feel that you’re going to be treated different,
you feel that they’re going to use you … based on what
you heard from your grandmother, what you heard from her sisters,
what you heard from your aunts, what you heard from your
mother.

“I always say, you never know unless you actually do it.
Nobody can force you to stay in any type of study. I say go for it.
You may just be like me where it’s almost a year-and-a-half
that I haven’t picked up a cigarette. I save more money and
it’s a better health environment for my kids.”

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